Known in the are is a number of cardiotropic medicaments, in particular a pharmaceutical composition, Ildamen-novodigal (patent No. 3332 Arzneim . U.el,Forsch (Drug Res.),25,Nr.3 (1975), F. Stroman und R. Hempel. Kombination yon Oxyfedrin mit 3-acetildigoxin), which is referenced here as the prior art to a cardiotropic formulation of the invention known under trade name Refrakterin.
The Ildamen-novodigal formulation including 0.2 mg of beta-acetyldigoxin and 18 mg of oxyfedrin is in common use for treatment of a cardiac insufficiency including conditions associated with coronary circulatory failure. Depending on the severity of patient's condition a daily medication of the combination may be increased up to 0.6 mg of beta-acetyldigoxin and 36 mg of oxyfedrin, and the treatment period may be longed for 1 month. The action of the combination of beta-acetyldigoxin and oxyfedrin is based on a positive inotropic synergism. Such combination of beta-acetyldigoxin and oxyfedrin provides a considerable decrease in toxicity of the former, prevents the occurence of bradycardia and arrhythmia thereby increasing the patient's drug tolerance. However, despite wider range over curable and toxic doses of beta-acetyldigoxin combined with oxyfedrin, the gap between them is still small.
The usage of such combination may cause of intoxication, especially in cases of cardiac hypersensivity to glycosides, in patients with myocardial inflammations, particularly in patients with influenza-related or acute isolated myocarditis, and alcohol-drinker's cardiomyopathy.
The usage of beta-acetyldioxin in combination with oxyfedrin at a considerably lower dose than that of the ildamen-novodigal formulation in cardiomyocyte energy-deficient conditions, such as a well-defined heart insufficiency arising from a toxic-allergic myocarditis, may cause non-responsiveness of the myocardial contractile protein system (Tabl.2) which will aggravate the energy-deficient state of cardiac muscle cell (Tab.3).
If such compounds are used individually, the enhancement of myodynamia of contractile proteins are accompanied with a considerable rise in ATP, and yet CP (creative phosphate) decreases in content. (Tabl.3). As a consequence of the deterioration of a metabolic state, there occurs the activation of myocardial and cardiomyocyte degeneration (N. N. Kipshinidze et al., 1983, Materialy nauchnoi sessii NIl klinicheskoi i eksperimentalnoi terapii Minzdrava Gruzii). This phenomenon may be considered to be the basis of cardiac refractory reaction to the conventional methods of treatment.
The object of the present invention is to provide a cardiotropic formulation, which medicative effect together with a low toxicity, will allow one to restore myocardial contractile force and increase the compensation abilities in a well-defined and severe heart failure including cardiac insufficiency with refractory reaction to the conventional methods of treatment and to cut the time for attaining positive results.